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Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

ConditionsHealthy Volunteer StudyHepatic ImpairmentRenal Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAtea Pharmaceuticals, Inc.

About this trial

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug

Females must have a negative pregnancy test at Screening and prior to dosing

BMI of 18.5 to 43.0 kg/m2

Willing to comply with the study requirements and to provide written informed consent

Disqualifiers

Pregnant or breastfeeding

Infected with hepatitis B virus, hepatitis C virus or HIV

Abuse of alcohol or drugs

Use of other investigational drugs within 28 days of dosing

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

    Drug

    A single dose of BEM/RZR will be administered

Treatment groups

28 Participants
are divided into 3 treatment groups
Group A: Group 1 - Severe Renal ImpairmentExperimental treatment 1 intervention
Group B: Group 2 - Severe Hepatic ImpairmentExperimental treatment 1 intervention
Group C: Group 3 - Matched Healthy SubjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)

Time frame
Day 1
2

Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)

Time frame
Day 1
3

Pharmacokinetics (PK) of BEM/RZR AUC

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atea Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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